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Senior Quality, Compliance, and Regulatory Engineer

CAI

Job Location:

Boston, MA - USA

Yearly Salary: USD 130000 - 175000

Posted: 29 September 2026 (11 hours ago)

Application Deadline: 27 December 2026

Vacancies: 1 Vacancy

Job Summary

Are You Ready

CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For Life Sciences and Mission Critical industries that need to deliver critical solutions in high-stakes environments we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach field tested processes and elite expertise developed over 30 years.

Our approach is simple because our Purpose informs everything we do:

We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience.

At CAI we are committed to living our Foundational Principles both professionally and personally:

We act with integrity

We serve each other

We serve society

We work for our future

At CAI we believe in a relentless dedication to excellence pushing boundaries and surpassing

expectations. From the beginning weve challenged ourselves to do what others wouldnt. Not just setting industry standards but redefining them entirely. We are bold in our thinking and creative in our approach. We operate at the intersection of wisdom and technology and thrive when they come together with humanity. For us operational readiness isnt simply a goal. Its a way of life. Because tomorrow demands to be at the forefront of today. We do this through tireless effort precision efficiency and an unwavering belief that there is always room for advancement. Were not interested in how it used to be done. Were obsessed with how it will be done.

Job Summary:

As the Senior Quality Compliance and Regulatory Engineer at CAI you will serve as both a strategic leader and subject matter expert. You will be responsible for building expanding and leading the Practice Area function ensuring excellence in service delivery and operational readiness and excellence.

This role involves active participation in business development activities including marketing direct sales and sales support across various regions. You will also play a key role in designing and implementing systems processes and initiatives that drive sustainable business growth.

Job Requirements:

1. Business Development & Industry Engagement:

Work collaboratively with CAI agents to sell QCR services and deliver strategic project work

Leverage your professional network to attract new business opportunities generate leads and secure assignments for consultants through proactive and targeted sales efforts

Engage in industry forums speaking writing articles participating in professional society committees support standards or guidance document creation within such groups

Build and maintain strong relationships with the regulatory authorities and other stakeholders as appropriate to ensure ease of access and influence.

2. Strategic & Expert Consulting

Consult clients in Quality Regulatory and Compliance areas

Fulfill Quality Regulatory and Compliance roles while managing client relationships for a portfolio of products and being responsible for close liaison with the management/ other key personnel in line with time frames per the project schedule.

Engage in strategic project work designed to be a door-opener for larger teams once the initial expert engagement is over or as part of a larger project to deliver specialized expertise.

3. Knowledge Leadership & Thought Contribution

Create and contribute to content in industry-changing approaches that will benefit CAI web site and marketing materials.

Provide significant support to PAL with respect to quality systems knowledge management services definition and delivery in your area of expertise.

4. Talent Development

Develop and grow agents through tailored professional development plans and initiatives

Qualifications:

BS or higher in Biotechnology Chemistry Pharmaceutical Manufacturing Technology Industrial Pharmaceutical Science Pharmaceutical Technology and Quality Systems Engineering or a related scientific discipline.

8 years experience in the life sciences industry with a proven track record of leading or collaborating effectively within cross-functional teams.

In-depth knowledge of cGMP systems Quality Assurance regulatory affairs pharmaceutical manufacturing and testing with direct experience in manufacturing environments.

Prior experience in sterile manufacturing biotechnology medical device and/or Cell and Gene is highly advantageous.

Demonstrated technical leadership in the development and implementation of a Quality Management Systems (QMS)

Leadership Competencies:

Leadership & Mentorship:

Leads and mentors teams influencing peers and stakeholders to achieve results.

Communication Skills:

Communicates clearly writes technical documents presents business ideas and fosters collaboration.

Decision-Making:

Makes sound timely decisions that benefit the team and broader organization. Gathers relevant information asks insightful questions and works with peers to identify optimal solutions

Business Acumen:

Delivers quality work finds improvement opportunities and simplifies processes.

Drive:

Shows initiative self-management and excellent organizational skills.

Regulatory & Data Compliance Expertise:

Knowledgeable in local and international data regulations ensuring integrity security and compliance.

Technical & cGMP Expertise:

Skilled in cGMP environments covering quality manufacturing production practices and systems.

Learning Agility & Problem-Solving:

Adaptable resolves issues effectively plans independently and collaborates well.

Positive Influence:

Addresses problems takes action seeks feedback and promotes continuous improvement. Influences outcomes positively.

Relationship Building:

Maintains strong relationships at all levels shares knowledge and communicates constructively.

#LI-MV1

$130000 - $175000 a year

Average salary range not including benefits or compensatory time and possible discretionary bonuses.

CAI Benefits:

Comprehensive Health Insurance coverage

24 days of Paid Time Off

Company paid Life Insurance

Company paid Long Term Disability

We are an equal opportunity employer; we are proud to employ veterans and promote a diverse culture in our workplace. Diversity is a strength for our global pledge that CAI will be operated in a way that is fair and equitable to all our employees our customers and the broader society.

This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the FCO.

We may use artificial intelligence (AI) tools to support parts of the hiring process such as reviewing applications analyzing resumes or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed please contact us.

Required Experience:

Senior IC

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